AddictionPhase 4NCT01870882
Attention Training for Opioid-maintained Cocaine Users
A Phase 4 study testing Attentional retraining in people with Addiction and Cocaine, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to determine the feasibility and preliminary efficacy of attention training using a portable electronic device for opioid-dependent cocaine-users stabilized on methadone. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- What is being tested?
- Attentional retraining
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jun 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Current opioid dependence as evidenced by 1) documentation of prior treatment for opioid dependence or signs of withdrawal, 2) self-reported history of opioid dependence for 12 consecutive months and, 3) a positive urine toxicology screen for opiates.
- Diagnosis of opioid dependence and cocaine dependence as well as laboratory confirmation of recent cocaine use in the form of positive urine toxicology during the month prior to study entry.
- For those who recently participated in a research study involving medications other than methadone, at least 2 weeks of washout period before enrollment. Those already taking methadone would continue with their current course while participating in this study.
- A history of cocaine use, a minimum of 1/2 gram and more than once per week during the preceding 30 days.
- Must be seeking treatment for opioid and cocaine use.
- For women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy and monthly pregnancy tests.
- The ability to speak, read, and write in English at an eight-grade literacy level.
Who cannot join
- Serious medical illnesses including hypertension, tachycardia, bradycardia, or other arrhythmias and major cardiovascular, cerebrovascular, renal, endocrine, or hepatic disorders;
- Serious psychiatric illness, history of psychosis, schizophrenia or bipolar type I disorder.
- Current major depression. Subjects with current depressive symptoms not meeting criteria will be included in the study, with the exception of those endorsing suicidal and homicidal thoughts, will be excluded even if full criteria for major depression are not met.
- Current diagnosis of alcohol or drug dependence other than opiates, cocaine, nicotine and cannabis.
- Current use of over-the-counter or prescription psychoactive drugs (antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants) or drugs that would be expected to have major interactions with drugs to be tested, e.g., benzodiazepines, codeine, percocet, and other opiate drugs that will interact with methadone.
- Liver function tests (ALT or AST) greater than 3 times normal.
- Self-reported color blindness or (non-corrected) defective vision
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Veterans Affairs Hospital
West Haven, Connecticut, 06516
About this study
The purpose of this study is to determine the feasibility and preliminary efficacy of attention training using a portable electronic device for opioid-dependent cocaine-users stabilized on methadone.
Read the detailed description
The investigators propose to test the feasibility and preliminary efficacy of 5-times per week daily attentional retraining (AR) delivered via a portable electronic device (PED) in comparison with a control condition over the course of a 2-3 week training period. Participants in this study will be cocaine and opioid-dependent individuals stabilized on methadone. Both cocaine and opioids will be targeted in the AR procedure the investigators will test in this study. The retraining or control condition, along with a series of assessments, will be delivered on the PED as part of a daily (Monday through Friday) appointment at which time participants will also obtain their daily methadone dose. Assessments will cover substance use, craving and other issues. In addition to completing the retraining or control procedure, participants will also be engaged in standard versions of attentional bias tasks (i.e., without retraining) periodically in order to gauge an effect of study condition on attentional bias over time. Thus, the investigators will be able to track changes in attentional bias over time in a more detailed fashion than has been previously possible. Following the 3 week training period, there will be another 3 weeks of treatment in which patients will continue to receive methadone and complete limited assessments without any AR or control procedures with the PED.
- Being tested
- Attentional retraining, Control condition
- Keywords
- Opioid-Related Disorders, Cocaine-Related Disorders, Substance-Related Disorders, Mental Disorders, Cocaine, Methadone, Therapeutic Uses
- Medical subject headings
- Behavior, Addictive, Opioid-Related Disorders, Cocaine-Related Disorders, Substance-Related Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attentional retrainingBehavioural
Also called attentional training, attentional bias retraining
Control conditionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Retraining | Active comparator | Using the PED, participants repeatedly complete a version of attentional bias task that orients their attention away from drug-related cues. Receives: Behavioral: Attentional retraining |
| Control | Sham comparator | Using the PED, participants repeatedly complete versions of the attentional bias task in which their attention is oriented toward and away from drug-related cues on an equal number of trials. Receives: Behavioral: Control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attentional bias for cocaine cues
The tendency to respond more rapidly to a dot probe when the probe replaces a cocaine-related word than when a dot probe replaces a matched, non-drug control word.
Measured: over the course of the 3 week training period
Attentional bias for opioid cues
The tendency to respond more rapidly to a dot probe when the probe replaces an opioid-related word than when a dot probe replaces a matched, non-drug control word.
Measured: over the course of the 3 week training period
Retention of participants in treatment
Measured: at the end of the 3 week training period
Mean duration of sessions with the PED
Measured: the duration of the 3 week training period
Secondary outcomes (6)
self-reported craving for cocaine
Measured: assessed on a daily basis during the 3 week training period
Self-reported cocaine use
Measured: during the 3 week training period
Self-reported opioid use
Measured: during the 3 week training period
self-reported craving for opiates
Measured: assessed on a daily basis during the 3 week training period
Cocaine urine test results
Measured: during the 3 week training period
opioid urine test results
Measured: during the 3 week training period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AddictionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert F Leeman, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870882
- Sponsor's protocol ID
- 1303011711
- Status last verified
- Mar 2020
- First submitted
- 3 Jun 2013
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention Training for Opioid-maintained Cocaine Users
- ClinicalTrials.gov ID
- NCT01870882
- Acronym / sponsor ID
- 1303011711
- Keywords
- Opioid-Related Disorders, Cocaine-Related Disorders, Substance-Related Disorders, Mental Disorders, Cocaine, Methadone, Therapeutic Uses
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the feasibility and preliminary efficacy of attention training using a portable electronic device for opioid-dependent cocaine-users stabilized on methadone.
Detailed description
The investigators propose to test the feasibility and preliminary efficacy of 5-times per week daily attentional retraining (AR) delivered via a portable electronic device (PED) in comparison with a control condition over the course of a 2-3 week training period. Participants in this study will be cocaine and opioid-dependent individuals stabilized on methadone. Both cocaine and opioids will be targeted in the AR procedure the investigators will test in this study. The retraining or control condition, along with a series of assessments, will be delivered on the PED as part of a daily (Monday through Friday) appointment at which time participants will also obtain their daily methadone dose. Assessments will cover substance use, craving and other issues. In addition to completing the retraining or control procedure, participants will also be engaged in standard versions of attentional bias tasks (i.e., without retraining) periodically in order to gauge an effect of study condition on attentional bias over time. Thus, the investigators will be able to track changes in attentional bias over time in a more detailed fashion than has been previously possible. Following the 3 week training period, there will be another 3 weeks of treatment in which patients will continue to receive methadone and complete limited assessments without any AR or control procedures with the PED.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retraining | Active comparator | Behavioral: Attentional retrainingUsing the PED, participants repeatedly complete a version of attentional bias task that orients their attention away from drug-related cues. |
| Control | Sham comparator | Behavioral: Control conditionUsing the PED, participants repeatedly complete versions of the attentional bias task in which their attention is oriented toward and away from drug-related cues on an equal number of trials. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Current opioid dependence as evidenced by 1) documentation of prior treatment for opioid dependence or signs of withdrawal, 2) self-reported history of opioid dependence for 12 consecutive months and, 3) a positive urine toxicology screen for opiates.
- Diagnosis of opioid dependence and cocaine dependence as well as laboratory confirmation of recent cocaine use in the form of positive urine toxicology during the month prior to study entry.
- For those who recently participated in a research study involving medications other than methadone, at least 2 weeks of washout period before enrollment. Those already taking methadone would continue with their current course while participating in this study.
- A history of cocaine use, a minimum of 1/2 gram and more than once per week during the preceding 30 days.
- Must be seeking treatment for opioid and cocaine use.
Key exclusion criteria (7 listed)
- Serious medical illnesses including hypertension, tachycardia, bradycardia, or other arrhythmias and major cardiovascular, cerebrovascular, renal, endocrine, or hepatic disorders;
- Serious psychiatric illness, history of psychosis, schizophrenia or bipolar type I disorder.
- Current major depression. Subjects with current depressive symptoms not meeting criteria will be included in the study, with the exception of those endorsing suicidal and homicidal thoughts, will be excluded even if full criteria for major depression are not met.
- Current diagnosis of alcohol or drug dependence other than opiates, cocaine, nicotine and cannabis.
- Current use of over-the-counter or prescription psychoactive drugs (antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants) or drugs that would be expected to have major interactions with drugs to be tested, e.g., benzodiazepines, codeine, percocet, and other opiate drugs that will interact with methadone.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attentional retrainingAlso: attentional training, attentional bias retraining | Behavioural | Retraining |
| Control condition | Behavioural | Control |
Primary outcome
Attentional bias for cocaine cues
Time frame: over the course of the 3 week training period
The tendency to respond more rapidly to a dot probe when the probe replaces a cocaine-related word than when a dot probe replaces a matched, non-drug control word.
Attentional bias for opioid cues
Time frame: over the course of the 3 week training period
The tendency to respond more rapidly to a dot probe when the probe replaces an opioid-related word than when a dot probe replaces a matched, non-drug control word.
Retention of participants in treatment
Time frame: at the end of the 3 week training period
Mean duration of sessions with the PED
Time frame: the duration of the 3 week training period
6 secondary outcomes
self-reported craving for cocaine
Time frame: assessed on a daily basis during the 3 week training period
Self-reported cocaine use
Time frame: during the 3 week training period
Self-reported opioid use
Time frame: during the 3 week training period
self-reported craving for opiates
Time frame: assessed on a daily basis during the 3 week training period
Cocaine urine test results
Time frame: during the 3 week training period
opioid urine test results
Time frame: during the 3 week training period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert F Leeman, Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Attentional retraining in people with Addiction and Cocaine, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attentional bias for cocaine cues (time frame: over the course of the 3 week training period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020; AzTrials last refreshed its copy on 28 Oct 2026.